Clinical Trial Summary

This pilot randomized control trial will examine the role of choral singing on psychosocial
stress and cardiovascular outcomes in patients with ischemic heart disease (IHD). The
hypothesis is that choral singing will improve psychosocial stress in comparison to the
control group and this may have an impact on rates of hospitalization, death, myocardial
infarction and stroke in these patients.

Clinical Trial Description

Objectives:

The purpose of this pilot study is to examine the impact of choral singing on psychosocial
stress and major cardiovascular events in patients with IHD in comparison to usual medical
care.

Recruitment and Randomization:

Participants will be recruited from community cardiac rehabilitation programs with
recruitment presentations, phone calls and mailed invitations. Interested participants will
complete baseline questionnaires and provide consent. They will be randomly allocated to
either the intervention or control group. Stratification by past or present experience in
organized singing (as a binary variable, yes or no) will be used.

Baseline Assessment:

All participants will undergo a baseline assessment, comprised of biophysical characteristics
and medical history; level of physical activity self reported by International Physical
Activity Questionnaire (IPAQ) long form; assessment of music appreciation and current
participation in group singing; and three questionnaires measuring psychosocial stress: the
Perceived Stress Scale (PSS), Hospital Anxiety and Depression Scale (HADS) and the Standard
Form - 36 (SF - 36).

Intervention:

Participants in the intervention group will participate in weekly 60-90 minute singing
sessions led by professional musicians over a 12-week period. Sessions will begin with a
5-minute physical warm-up of gentle stretching and a 5-minute vocal warm-up. Music will be
selected from a variety of genres and eras. Attendance will be taken weekly.

Control:

The control group will receive usual medical care. If control group participants join a
singing group during the study period they will not be excluded, but this data will be
collected and considered.

Analysis:

Data analysis will be done blind with respect to participant allocation. Analysis will
include and account for attendance or adherence to consider dose response. Only participants
who have attended at least 50% of group singing sessions will be included. A sub-group
comparison between those who have attended 50-74% of sessions and those who have attended
≥75% will be done to determine if there is a dose-response effect to the weekly singing
sessions. Participants who join another singing group during or after the intervention period
will not be excluded, but this will be taken into account. The concept of music "responders"
and "non-responders" will be considered based on the initial screening question "How
important is music in your day-to-day life?".
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Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.

Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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